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Recall Observatory FDA recall evidence

Device product

Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures

Z-0866-2017

November 21, 2016

Class II

Product summary

Firm
Northgate Technologies, Inc.
Event
Event 75716
Status
Terminated
Classification
Class II
Quantity
49 devices
Official record key
device-enforcement:Z-0866-2017

Official wording

Reason: Device could cause a patient overpressure situation without any visual or auditory indication or warning

Code information: Serial Numbers: #89170HXB, #89556DYD, #89652FYA, #89661FYA, #89663FYA, #89664FYA, #89670FYA, #89672FYA, #89675FYA, #89677FYA, #89685FYB, #89697FYB, #89708GYA, #89713GYA, #89719GYB, #89720GYB, #89729GYB, #89732GYB, #89734GYB, #89737GYB, #89889IYD, #90165AZB, #90285BZD, #90387DZB, #90391DZB, #90415DZD, #90438DZD, #90469EZB, #90528EZD, #90555FZB, #90556FZB, #90557FZB, #90558FZB, #90561FZB, #90583GZC, #90621GZB, #90654HZB, #90739IZD, #90869KZD, #90931LZD, #90936LZD, #90954LZD, #90962LZD, #90972LZD, #91105CAD, #91108CAD, #91114CAD, #91120CAD, #91380FAC, #91406FAD, #91471GAC, #91544IAC

Distribution pattern: Worldwide Distribution - US including FL and MA. Internationally to Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Device could cause a patient overpressure situation without any visual or auditory indication or warning